Nano-drug Clinical Trials: Informed Consent and Risk Management Through Blockchain

  • Yousef Haik
  • Ilias Bantekas

Abstract

Drug bearing nano-shells that can be utilized for targeted drug delivery have been shown to enhance the therapeutic index by increasing the dug concentration in diseased tissue and reducing the toxicity in normal tissue.  The controllability of the drug bearing shell size provides predictability measure for the amount of drug payload per shell which improves the administration of the therapeutic dose.  The FDA approved different formulations for clinical use in metastatic and recurrent breast cancer, among other diseases.  At the moment, some of these formulations are the subject of international clinical trials.  Informed consent is legally mandated in administering drug bearing nano-shells.  The risks of the new formulations, as with all new technologies, are not well known and are continue to be a subject of intensive research, thus exacerbating the existing informed consent legal issues, thus exacerbating the existing informed consent legal issues.  This short essay focuses on proposing a framework to mitigate liabilities administering a new formulation on nano-enabled drug carriers particularly when uncertainties of the benefits and damages are not fully known. 

Author Biographies

Yousef Haik
Professor, Department of Mechanical and Industrial Engineering, Texas A & M University-Kingsville, TX78363
Ilias Bantekas
Professor of Law, Hamad bin Khalifa University (Qatar Foundation), College of Law and Adjunct Professor, Georgetown University, Edmund A Walsh School of Foreign Service.
Published
2021-03-17
How to Cite
Haik, Y., & Bantekas, I. (2021). Nano-drug Clinical Trials: Informed Consent and Risk Management Through Blockchain. Pittsburgh Journal of Technology Law &Amp; Policy, 21(1). https://doi.org/10.5195/tlp.2021.243
Section
Articles